BOSTON SCIENTIFIC NEUROMODULATION INFINION 16 LEAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-2316-50E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994)
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Event Date 05/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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Model number/catalog number: sc-2316-50e, serial number: (b)(4), batch/lot number : 5054915, model/catalog description: infinion 16 trial lead kit 50 cm.
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Event Description
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A report was received that within a trial, the patient had an infection at the lead site.Symptoms of inflamed, redness and soreness were noted.It was also reported that the patient experienced abscess during hospitalization which caused difficulty walking.The patient was placed on antibiotics through peripherally inserted central catheter (picc) line and underwent a lead pull procedure.
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Manufacturer Narrative
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Additional information was received that the patient was naturally susceptible to getting infections, and that there was nothing that happened during the procedure that would cause infection.Model number/catalog number: sc-2316-50e, serial number: (b)(4), batch/lot number : 5054915, model/catalog description: infinion 16 trial lead kit 50 cm.A review of the manufacturing documentation for the ipg and lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices were found to be satisfactory.
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Event Description
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A report was received that within a trial, the patient had an infection at the lead site.Symptoms of inflamed, redness and soreness were noted.It was also reported that the patient experienced abscess during hospitalization which caused difficulty walking.The patient was placed on antibiotics through peripherally inserted central catheter (picc) line and underwent a lead pull procedure.
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